Efficacy of Tofacitinib in Reduction of Spinal Inflammation Detected on MRI in Patients with Psoriatic ArthritiS

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 80

Inclusion Criteria

Subject =18 and <65 years of Age with written informed consent
Diagnosis of PsA by their treating rheumatologist and subject fulfilling ClASsification criteria for Psoriatic ARtrhitis (CASPAR)
Evidence of axial involvement (e.g. active inflammation, structural changes), that have been demonstrated by previous imaging techniques (e.g. X-ray, MRI, computed tomography).
Presence of chronic (duration =3 months) back pain, BASDAI value of =4 and back pain score (BASDAI Question 2) of =4 (on a 0 – 10 Numeric Rating Scale-NRS) at screening and baseline.
Presence of active inflammation (bone marrow edema) on screening MRI of the sacroiliac joints and/or spine according to the definition of Assessment of SpondyloArthritis international Society (ASAS) MRI working group (evaluated by central reader of screening MRI).
History of an inadequate response to at least two different NSAIDs over a period of 4 weeks in total at the maximum recommended or tolerated doses or intolerance/contraindication for NSAIDs.
Subjects of reproductive potential must use contraceptive methods.
Subjects taking corticosteroids must be on an average daily dose of =10mg/day prednisone or equivalent for at least 14 days prior to the Baseline visit. Subjects taking Methotrexate (=25mg /week) or Sulfasalazine (up to 3g/day) are allowed to continue their medication if started at least 12 weeks prior to Baseline, with a stable dose for at least 4 weeks before randomization.
Subjects with previous biologic DMARDs will be allowed entry into study after appropriate wash-out periods as defined in protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- significant acute or chronic infections including Tuberculosis, HBV/HCV/HIV and Herpes zoster as defined by protocol
- pregnancy and breastfeeding
- other chronic inflammatory articular disease (other than psoriasis or PsA)
- treatments with DMARDs other than methotrexate or sulfasalazine (e.g. Leflunomide, Hydroxychloroquine or Apremilast) within 4 weeks prior to baseline (in case of Leflunomide either 8 weeks or 4 weeks with a standard cholestyramine wash-out).
- Prior treatment with Tofacitinib or another JAK-inhibitor.
- Current participation in another interventional study. If subjects participated in another study of any investigational drug, there must be an appropriate wash-out period prior to the Baseline Visit.
- Actual malignancies or history of malignancies with curative treatment within 5 years prior to screening, except successfully treated non-metastatic squamous cell or basal cell carcinoma of the cutis or carcinoma in situ of the cervix
- A subject with any condition possibly affecting oral drug absorption, e.g., gastrectomy...
- Significant trauma or surgery procedure within 4 weeks prior to baseline, or any planned elective surgery during the study period.
- Evidence of other severe uncontrolled gastrointestinal, hepatic (serum albumin <25 mg/l or Child-Pugh-Score >10), renal, pulmonary, cardiovascular, nervous or endocrine disorders.
- Any subject who has been vaccinated with live or attenuated vaccines within the 4 weeks prior to the first dose of study medication or is to be vaccinated with these vaccines at any time during treatment or within 4 weeks after the last dose of study drug.
- laboratory abnormalities as defined in protocol.
- Patients who are defined as vulnerable patients according to Art. 10 REGULATION (EU) No 536/2014: patients who are institutionalized due to regulatory or juridical order; patients who are an employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site; family members of the aforementioned employees or the investigator.
- Patients with contraindications for the MRI including but not limited to: claustrophobia, seizure disorders, presence of an implanted electronic device (e.g., heart pacemaker, insulin pump, etc.) or metal implants not known to be MRI safe and metal foreign bodies in the patient’s body suspected to be ferromagnetic, tattoos performed with metal-containing paints or tattoos of large skin areas.